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Apneic Oxygenation for Morbid Obese Parturient in cs

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
nasal prong
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2.
  2. ASA physical status I-II
  3. Age above 18 years.
  4. Scheduled for elective caesarean section under general anesthesia.

Exclusion Criteria:

  1. Parturient of ASA physical status III or above.
  2. Suspected or known difficult airway (Mallampati class > 2, reduced neck movement, reduced mouth opening, or Cormack-Lehane grade 4 recorded during a previous intubation procedure).
  3. Any contraindication for nasal prong use, for example, tumours, fractures or trauma.
  4. SpO2 ≤ 97% prior to preoxygenation.

Sites / Locations

  • Ain Shams university
  • Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

nasal prong.

conventional

Arm Description

the apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong.

the conventional preoxygenation group (30 patients)

Outcomes

Primary Outcome Measures

the lowest oxygen saturation recorded
percentage

Secondary Outcome Measures

rates of desaturation below SpO2 90%
percentage
rates of critical desaturation below SpO2 80%
percentage

Full Information

First Posted
August 20, 2021
Last Updated
June 3, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05021549
Brief Title
Apneic Oxygenation for Morbid Obese Parturient in cs
Official Title
Effectiveness of Apneic Oxygenation for Morbid Obese Parturient Performing Elective Caesarean Section Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to compare the effect of apneic preoxygenation to conventional preoxygenation on the oxygen desaturation in morbid obese parturient performing elective caesarean section under general anesthesia.
Detailed Description
Anesthetic management of the obese parturient is challenging. Both pregnancy and obesity are risk factors for a difficult airway and anesthesia-related maternal mortality. There is increased risk of difficult intubation associated with an increased difficultly in mask ventilation and increased risk of accelerated desaturation during apnea. The use of apneic oxygenation for the optimization of peri-intubation conditions is a promising means of preventing hypoxemia. Despite the recommendation of the use of nasal prongs to insufflate oxygen at flows of 5 L/min to 15 L/min during the apneic period randomized controlled trial is still not available in the morbidly obese parturient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2. ASA physical status I-II Age above 18 years. Scheduled for elective caesarean section under general anesthesia.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nasal prong.
Arm Type
Active Comparator
Arm Description
the apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong.
Arm Title
conventional
Arm Type
No Intervention
Arm Description
the conventional preoxygenation group (30 patients)
Intervention Type
Device
Intervention Name(s)
nasal prong
Intervention Description
apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia
Primary Outcome Measure Information:
Title
the lowest oxygen saturation recorded
Description
percentage
Time Frame
during intubation procedure
Secondary Outcome Measure Information:
Title
rates of desaturation below SpO2 90%
Description
percentage
Time Frame
during intubation procedure
Title
rates of critical desaturation below SpO2 80%
Description
percentage
Time Frame
during intubation procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Morbid obesity parturient defined as a body mass index (BMI) above 40 kg/m2. ASA physical status I-II Age above 18 years. Scheduled for elective caesarean section under general anesthesia. Exclusion Criteria: Parturient of ASA physical status III or above. Suspected or known difficult airway (Mallampati class > 2, reduced neck movement, reduced mouth opening, or Cormack-Lehane grade 4 recorded during a previous intubation procedure). Any contraindication for nasal prong use, for example, tumours, fractures or trauma. SpO2 ≤ 97% prior to preoxygenation.
Facility Information:
Facility Name
Ain Shams university
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
Facility Name
Faculty of medicine
City
Cairo
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD to be shared
IPD Sharing Time Frame
after finishing the study
IPD Sharing Access Criteria
clinicaltrial web site

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Apneic Oxygenation for Morbid Obese Parturient in cs

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